Quality & Regulatory Manager - Remote

Overview

The Quality & Regulatory Manager will centrally manage a Lean and compliant Quality Management system for medical devices schemes, ensuring regulatory compliance and overseeing audits.

In Short

• Manage a Lean and compliant Quality Management system for medical devices.
• Oversee internal and external audits and manage communications with authorities.
• Maintain accreditation under relevant medical device regulations.
• Coordinate regulatory training programs and ensure compliance.
• Compile and analyze data for management reviews.
• Lead a team in Quality & Regulatory functions.
• Ensure QMS aligns with global processes and accreditation requirements.
• Build relationships with global medical device teams.
• Provide technical support across the business.
• Responsible for updating the Quality Management System.

Requirements

• 5+ years in Quality Assurance or Regulatory assurance in a Notified Body.
• 2+ years in team management.
• Strong knowledge of Medical Device Regulations and ISO standards.
• Excellent interpersonal and communication skills.
• Ability to work with senior management and other stakeholders.
• Strong organizational skills and attention to detail.
• Higher education qualification in a relevant life/natural sciences subject.
• Completed Medical device training on relevant regulations.

Benefits

• Flexible schedule and hybrid model.
• Continuous learning options through SGS university.
• Multinational work environment.
• Benefits platform for employees.
• Supportive and inclusive work environment.